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STA, PhoenixMD Enter Manufacturing Agreement

To manufacture the PMD-026 needed for IND-enabling toxicology studies and a Phase I study in women

By: Betsy Louda

, Contract Pharma

Phoenix Molecular Designs (PhoenixMD), has entered into a collaboration with STA Pharmaceutical Co., Ltd (STA), a WuXi AppTec group company, to manufacture the PMD-026 needed for IND-enabling toxicology studies and a Phase I study in women.

 

Under the terms of the collaboration agreement, STA will become a new manufacturing partner for PhoenixMD for their platform of kinase inhibitor drug candidates to treat a wide range of unmet medical needs, with an initial focus on triple negative breast cancer (TNBC).  STA will be responsible for the early manufacturing work through their GMP-certified site in San Diego, CA.  Through these collaborative efforts, PhoenixMD expects to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for PMD-026. 

 

Dr. Minzhang Chen, chief executive officer of STA, commented, “We are excited to manufacture PMD-026 and enable Phoenix MD to advance this novel RSK inhibitor to shrink tumors in Phase 1 studies in women.”

 

“We’re thrilled to collaborate with STA, a global leader in drug development and manufacturing, who has helped us achieve an important milestone in the efficient and scalable manufacturing of PMD-026,” said Sandra E. Dunn, chief executive officer at PhoenixMD.  “Through this work, we have demonstrated that PMD-026 has the potential to be disease-modifying with its ability to block the RSK pathway signaling and initiating significant tumor shrinkage of up to 70% in TNBC xenograft models.  Looking ahead, we expect to build upon this progress and file an IND for PMD-026, with the ultimate goal of confirming these revolutionary results in women suffering from TNBC.”

 

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